defective device

How often do you read warning labels on the products you use regularly? And how much weight do you give those warnings?

FDA Requiring Bayer to Complete A Post-Market Study

The Food and Drug Administration has announced a new requirement for Essure packaging: warning labels and a patient decision checklist. The FDA will also require Bayer, the medical device’s manufacturer, to conduct post-market studies of the sterilization coils. This decision comes after more than 5,000 adverse event reports from women who have had Essure implanted in their Fallopian tubes. The device, designed to permanently prevent pregnancy, has been known to break apart and move around within the body. For some women, these complications have meant chronic headaches, bleeding, unintended pregnancies and even hysterectomies. The FDA is now requiring Bayer to complete a post-market study of the device.

Some Say the Essure Device Should be Recalled

For some anti-Essure advocates, the FDA’s requirements don’t go far enough to protect women who might consider using Essure. Though the studies required of Bayer might seem like a good idea to better understand the potential problems with the device, Essure remains in the marketplace, potentially harming countless other women as the research is conducted. As long as Essure remains on the market, the critics say, there is risk for women.

When the Risks Outweigh the Benefits

The decision to choose the birth control that is right for you is a critical one. We need to ensure women have all the facts about a given product, and when that product’s risks outweigh its benefits, it needs to be taken off the shelf. No woman would expect to experience the symptoms related to this device, nor would they anticipate needing multiple surgeries to remove Essure. Yet this exact scenario has occurred time and time again. The study and its results should have been factored into the initial approval of the product, not an afterthought more than a decade after its release.

While we applaud the FDA for implementing the new warning label requirement of Bayer, more needs to be done to protect the women who are considering using Essure.

Free Consultation, No Fee Promise.

The Law Offices of Richard J. Serpe, PC are currently investigating potential injury claims for anyone who has suffered from complications or has been seriously injured by an Essure permanent birth control device.

If you or a loved one has suffered from an injury related to an Essure permanent birth control device, you may want to contact an attorney. Our dangerous and defective products attorneys offer a free, no obligation, consultation. Additionally, our no fee promise means you don’t owe us any legal fees unless we settle or win your case. Contact us to discuss your situation today 877-544-5323.

We trust the companies we buy from to have our best interests in mind. After all, our best interests are their best interests, right? Unfortunately, this isn’t always true – and that’s where federal oversight of the products we buy and use daily is so important. But what if federal agencies like the Food and Drug Administration didn’t have all the facts presented to them accurately?

In 2014, a plaintiff claimed that Bayer, the creator of Essure, actively concealed negative reports from the Food and Drug Administration. This concealment allowed for the pharmaceutical giant to gain premarket approval for the device, which guards a company against product liability lawsuits. The lawsuit also claims that doctors were inadequately trained in the implanting process. Three coils – instead of the intended two – were implanted into the plaintiff’s Fallopian tubes, eventually leading to five hospitalizations and a hysterectomy.

Two years later, the FDA has mandated new warnings for Essure. It recently announced it will require black box warning labels for the device, calling attention to “serious or life-threatening risks.” The FDA will also require Bayer to study women undergoing the sterilization process, be it through Essure or another method.

Still, some advocates say this is not enough. The device still remains on the market and there is no enforcement for the FDA’s recommendations for Bayer. “I feel as if the FDA truly failed these women,” one advocate told CNN.

More than 5,000 adverse events have been reported to the FDA in the years following the approval of Bayer’s Essure permanent birth control device. Complaints range from abdominal pain to unintended pregnancy to organ perforation.

Free Consultation, No Fee Promise.

The Law Offices of Richard J. Serpe, PC are currently investigating potential injury claims for anyone who has suffered from complications or has been seriously injured by an Essure permanent birth control device.

If you or a loved one has suffered from an injury related to an Essure permanent birth control device, you may want to contact an attorney. Our dangerous and defective products attorneys offer a free, no obligation, consultation. Additionally, our no fee promise means you don’t owe us any legal fees unless we settle or win your case. Contact us to discuss your situation today 877-544-5323.

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